FDA accepts Lundbeck NDA for IV carbamazepine

The US subsidiary of Danish CNS specialist Lundbeck (LUND: CO) says that the Food and Drug Administration has accepted for review a New Drug for its investigational therapy intravenous carbamazepine an IV formulation of the anti-epileptic drug (AED) carbamazepine.

An action letter is anticipated before the end of 2014. Carbella is the proposed US trade name for intravenous carbamazepine, which has been licensed by Lundbeck from US drugmaker Ligand Pharmaceuticals (Nasdaq: LGND). The later says that, with acceptance of the NDA filing, Ligand earns a $200,000 milestone payment.

Oral carbamazepine is an important treatment option for people with epilepsy. However intravenous carbamazepine formulations are currently not available for patients unable to take the medication by mouth. Intravenous carbamazepine received orphan drug designation from the US FDA in 2013 and is proposed for use as replacement therapy in adults who are on a stable maintenance oral dose of carbamazepine to control certain seizure types when oral carbamazepine administration is temporarily not feasible.